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Recruitment status Completed
Unique ID issued by UMIN UMIN000015134
Receipt No. R000017602
Scientific Title The skin test environmental improvement by health care use.
Date of disclosure of the study information 2014/09/12
Last modified on 2015/04/27

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Basic information
Public title The skin test environmental improvement by health care use.
Acronym The skin test environmental improvement by health care use.
Scientific Title The skin test environmental improvement by health care use.
Scientific Title:Acronym The skin test environmental improvement by health care use.
Region
Japan

Condition
Condition Dry skin
Classification by specialty
Dermatology Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Comparison of the skin condition of the new product group and the current product group and the control group.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Inspection score (dryness)
Key secondary outcomes Inspection score (erythema),Skin moisturizing,Transepidermal water loss and determination in enlarged photograph , subject questionnaire.

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Double blind -all involved are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 3
Purpose of intervention Prevention
Type of intervention
Other
Interventions/Control_1 control group
Interventions/Control_2 current product group
Interventions/Control_3 new product group
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
70 years-old >=
Gender Male
Key inclusion criteria Person of dry skin.
Key exclusion criteria 1)Heavy sequela or severe disease.
2)Heavy atopic dermatitis or systemic skin diseases such as psoriasis.
3)Systemic administration of immunosuppressive drugs or steroids.
4)The person who is unsuitable for the entry judged by a doctor.
Target sample size 102

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kenichi Isoda, M.D.,Ph.D.
Organization Mie University Hospital
Division name Dermatology
Zip code
Address 2-174 Edobashi, Tsu, Mie 514-8507, Japan
TEL 059-232-1111
Email isoda@clin.medic.mie-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Koji Umeda,Ph.D.
Organization KSK Laboratories,Inc.
Division name representative
Zip code
Address t.c.p 4F,7-15 Daimon, Tsu, Mie 514-0027, Japan
TEL 059-253-8091
Homepage URL http://www.ksk-lab.co.jp
Email info@ksk-lab.co.jp

Sponsor
Institute Mie University, Graduate School of Medicine
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization KSK Laboratories,Inc.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 三重大学総合研究棟2

Other administrative information
Date of disclosure of the study information
2014 Year 09 Month 12 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2014 Year 08 Month 02 Day
Date of IRB
Anticipated trial start date
2014 Year 09 Month 13 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2014 Year 09 Month 11 Day
Last modified on
2015 Year 04 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017602


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